Sanofi announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes.
"This NDA submission is a significant milestone in Sanofi's efforts to further develop our insulin franchise," said Pierre Chancel, Senior Vice President, Head of Global Diabetes at Sanofi. "A large unmet medical need still exists for people with type 2 diabetes, as more than half are not at their blood sugar goal despite using oral medications or insulin. We recognize the need for additional treatment options and look forward to working with the FDA during their consideration of our submission."
Sanofi redeemed a priority review voucher (PRV) with the submission to designate the NDA for an expedited 6-month review if the submission is accepted by the FDA, instead of the standard 10-month review.
This NDA submission is based on data from the LixiLan-O and LixiLan-L Phase III studies, which both reported positive top-line results earlier in 2015. These studies enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations uncontrolled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively.
The proprietary name for the fixed-ratio combination is under consideration. Its safety and efficacy have not been evaluated by any regulatory authority.
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